Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02796573
Recruitment Status : Unknown
Verified May 2018 by Kim Mathiasen, University of Southern Denmark.
Recruitment status was:  Recruiting
First Posted : June 10, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Kim Mathiasen, University of Southern Denmark

Tracking Information
First Submitted Date  ICMJE June 1, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date May 11, 2018
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
Patient Health Questionnaire 9-item change [ Time Frame: Change from Baseline, 3 months, 6 months, 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy
Official Title  ICMJE Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy: A Randomised Non-inferiority Trial
Brief Summary

Depression is a prevalent and disabling disorder with great cost to the individual and the society. Lately, the use of internet interventions as guided self-help has demonstrated remarkable results. However, certain shortcomings such as lack of personal adaptation has been identified.

The presents study aims to investigate the potential of blending Internet based interventions with face-to-face consultations using cognitive behavioural therapy (B-CBT). The main hypotheses are, that that B-CBT will be as clinically effective as TAU, and that it will be acceptable to patients and clinicians.

The study is designed as a two arm randomised non-inferiority trial comparing internet based B-CBT for depression to treatment as usual (TAU) defined as 12 sessions of face-to-face CBT.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Adult Depression
Intervention  ICMJE Behavioral: cognitive behavioural therapy
Study Arms  ICMJE
  • Experimental: B-CBT
    6 face-to-face consultations plus 6 online modules.
    Intervention: Behavioral: cognitive behavioural therapy
  • Active Comparator: Face-to-Face CBT
    12 face-to-face consultations.
    Intervention: Behavioral: cognitive behavioural therapy
Publications * Mathiasen K, Andersen TE, Riper H, Kleiboer AA, Roessler KK. Blended CBT versus face-to-face CBT: a randomised non-inferiority trial. BMC Psychiatry. 2016 Dec 5;16(1):432.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Being 18 years of age or older.
  • Meet Diagnostic and Statistic Manual of Mental Disorders 4th. edition (DSM-IV) diagnostic criteria for major depressive disorder as confirmed by the telephone administered Mini International Neuropsychiatric Interview version 5.0 (MINI)and a score of 5 or higher on the Patient Health Questionnaire nine items (PHQ-9).

Exclusion Criteria:

  • Current high risk of suicide according to the MINI Interview section C.
  • Co-morbid substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview.
  • Currently receiving psychological treatment for depression in primary or specialised mental health care
  • Being unable to comprehend the spoken and written language of Danish.
  • Not having access to a computer and fast Internet connection (i.e. broadband or comparable)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796573
Other Study ID Numbers  ICMJE S-20150150
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kim Mathiasen, University of Southern Denmark
Study Sponsor  ICMJE University of Southern Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Southern Denmark
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP